Partnered rhythmic rehabilitation for early Alzheimer's disease
Partnered Rhythmic Rehabilitation for Enhanced Motor-Cognition in Prodromal Alzheimer's Disease
This study is testing if a fun dance program can help people with early Alzheimer's disease improve their thinking and movement skills compared to regular walking classes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04029623 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of partnered rhythmic rehabilitation (PRR) as an intervention for individuals with prodromal Alzheimer's disease (pAD). The study involves a phase II single-blind randomized design where participants will be assigned to either PRR or walking exercise classes over a one-year period. The intervention includes a three-month training phase followed by a nine-month maintenance phase, focusing on enhancing cognitive and motor functions through engaging social dance activities. The primary aims are to assess the safety, tolerability, and acceptability of PRR in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with amnestic mild cognitive impairment who are at risk for progression to Alzheimer's disease.
Not a fit: Patients with advanced Alzheimer's disease or those unable to participate in physical activities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve cognitive and physical functioning in patients with early Alzheimer's disease, potentially delaying progression to more severe stages.
How similar studies have performed: Previous studies have shown promise in using combined motor and cognitive training approaches for early Alzheimer's disease, suggesting potential success for this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Amnestic mild cognitive impairment (MCI) will be defined using the AD Neuroimaging Initiative (ADNI) criteria (http://www.adni-info.org/Scientists/ADNIStudyProcedures.aspx). All MCI participants in ADNI are required to have an amnestic subtype defined as: * Subjective memory concern or a memory problem noted by their partner * Abnormal memory function documented by a specified education adjusted cutoff score on the delayed paragraph recall of the Anna Thompson story of the Logical Memory subtest from the Wechsler Memory Scale-Revised * Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive). Exceptions may be made for subjects with less than 8 years of education at the discretion of the PI * Single or multi-domain amnestic MCI (both subtypes are at high risk for progression to AD) * Clinical Dementia Rating (CDR) = 0.5 (Memory Box score must be at least 0.5) * General functional performance sufficiently preserved * Ability to walk 10 or more feet without an assistive device * Completed six grades of education or has a good work history (sufficient to exclude intellectual disabilities) * Achieves less than 150 minutes of moderate intensity or 75 minutes of vigorous intensity aerobic activity per week, which is the recommended amount of weekly exercise as per the US Department of Health and Human Services. Not involved in any structured exercise program within the past 3 months (brisk walks are considered formal exercise but leisurely walks are not) * Not hospitalized within the last 60 days * Willing to commit to a one year research program Exclusion Criteria: * Acute medical illness requiring hospitalization * Uncontrolled congestive heart failure * History of stroke in the past three years * Inability to perform study procedures * Inability to perform MRI (e.g. metal implants or cardiac pacemaker, claustrophobia) * Medical or physical conditions that would preclude participation (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity) * On medications that could adversely affect cognition, eg: antipsychotics, opioids, stimulants, chemotherapy, anti-parkinsonian drugs (eg Levodopa), neurologic prescriptions to treat Multiple sclerosis and/or Parkinson's. Patients will also be excluded if they are not on stable doses of Aricept, or anticholinesterase inhibitors, eg Namenda, for at least 3 months * Psychotic disorders * Confounding neurologic conditions (e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness \>30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae) * Substance Use Disorder, Major Depressive and Generalized Anxiety Disorders within six months of evaluation
Where this trial is running
Atlanta, Georgia
- Emory University — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Madeleine Hackney, PhD — Emory University
- Study coordinator: Madeleine Hackney, PhD
- Email: mehackn@emory.edu
- Phone: 404-321-6111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.